Health Condition 1: N189- Chronic kidney disease, unspecified
Conditions
Interventions
Intervention1: NOT APPLICABLE as Non randomized, Non interventional study: NOT APPLICABLE as Non randomized, Non interventional study
Control Intervention1: NOT APPLICABLE as Non randomized, Non inter
Sponsors
AstraZeneca AB
AstraZeneca Pharma India Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1 Male or female aged greater than or equal to 18 years at the time of signing the informed consent 2 Express interest to participate in a future CKD clinical study 3 eGFR greater than or equal to 20 to less than 90 mL/ min/ 1.73 m square (eGFRcr[AS], Section 8.2.1) (Delgado et al 2022, Inker et al. 2021) 4 UACR greater than or equal to 700 mg/g or UPCR greater than or equal to 1000 mg/g based on urine sample at time of screening visit 5 Receiving RAS inhibitor therapy (ACEi or ARB) that has been at stable dosing for at least 4 weeks. Exceptions from this requirement will be made for participants who are unable to tolerate RAS inhibitor therapy 6 Provision of signed and dated written informed consent before any study-specific procedures
Exclusion criteria
Exclusion criteria: 1 Known NYHA class III or class IV Congestive Heart Failure at the time of enrolment 2 As per investigator judgement, patients who are not suitable and/or stable enough to participate in a phase 3 interventional study (eg, recent hospitalisation for HF, recent cardiac surgery or intervention, heart disease including stroke, life expectancy less than 2 years due to conditions other than renal or CV conditions, unable to commit for personal reasons to a phase 3 trial for up to 4 years) 3 Known T1DM 4 Known history of any life-threatening cardiac dysrhythmia (continuous or paroxysmal) 5 Known history of solid organ transplantation 6 Known history or ongoing allergy/hypersensitivity, as judged by the investigator, to SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin) or endothelin receptor antagonists (eg, ambrisentan, atrasentan, bosentan) 7 Known blood-borne diseases such as specified in Appendix B (category A and B) 8 Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site) 9 Inability of the patient, in the opinion of the investigator, to understand and/or comply procedures and/or follow-up or any conditions that, in the opinion of the investigator, may render the patient unable to complete the study 10 Known pregnancy at the time for the visit or have an intention to become pregnant 11 Lupus nephritis, anti-neutrophil cytoplasmic autoantibody vasculitis, minimal change disease, autosomal dominant polycystic kidney disease (polycystic kidney disease), Alport syndrome, patients on renal replacement therapy, or clinical nephrotic syndrome with problematic oedema 12 Unable to commit for personal reasons to a phase 3 clinical trial of up to 4 years duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To identify and characterise patients with CKD and high proteinuria. Below parameters are assessed. Age Sex T2DM (Y/N) HF + NYHA class (if known) ACEi (Y/N) ARB (Y/N) SGLT2i (Y/N) CKD aetiology eGFR UACR UPCRTimepoint: Summary statistics assessed at one single visit (at visit 1 which is one day) | — |
Secondary
| Measure | Time frame |
|---|---|
| To obtain an overview on current medication for patients with CKD & high proteinuria across different geographical regionsTimepoint: Summary statistics assessed at one single visit (at visit 1 which is one day) | — |
Countries
Argentina, Brazil, Canada, China, India, Mexico, Philippines, Poland, Slovakia, South Africa, Sweden, Taiwan, Thailand, Turkey, United States of America, Viet Nam
Contacts
Public ContactTapankumar M Shah
AstraZeneca Pharma India Ltd,
Outcome results
None listed